SOCIAL QUESTIONS|health|pharmaceutical industry
- críochphointe ionaid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- surrogate endpoint
- en
- Definition "in clinical trials, measure of the effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship" Reference "COM-Terminology Coordination, based on: COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Strengthening of the EU Cooperation on Health Technology Assessment (HTA) Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU"
- Comment For example, the serum cholesterol concentration may be considered a surrogate endpoint when assessing pharmaceuticals aiming to prevent complications of cardiovascular disease. However, only about 10% of those with serum cholesterol concentration above the reference range are going to have a stroke or heart attack. Therefore more relevant clinical endpoints could be the number of nonfatal myocardial infarction or stroke cases.
- marqueur de substitution | critère de substitution | critère d'évaluation de substitution
- fr
- Definition marqueur aisément mesurable qui permet, en l’absence de données cliniques, d’évaluer l’effet d’un traitement Reference "Délégation générale à la langue française et aux langues de France (DGLFLF), FranceTerme, fiche ""marqueur de substitution"" (30.7.2020)"